Anterior spinal implants for reducing spinal malalignment and associated systems and methods

ABSTRACT

Anterior spinal implant devices for reducing spinal malalignment and associated systems and methods are disclosed herein. A spinal implant system configured in accordance with embodiments of the present technology can include, for example, a first vertebral support implanted at an anterior region of a first vertebra of a patient, a second vertebral support implanted at an anterior region of a second vertebra inferior to the first vertebra, and an alignment system configured to be releasably coupled to the first and second vertebral supports. The first and second vertebral supports can extend into and interlock with each other within an interbody space between the first and second vertebrae when the first and second vertebral supports are aligned. The alignment system is configured to reduce angular, vertical, and linear malalignment of the first and second vertebrae relative to each other.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/376,893 filed on Apr. 5, 2019, which is a divisional of U.S. patentapplication Ser. No. 16/168,106 filed on Oct. 23, 2018 (now U.S. Pat.No. 10,441,322 issued Oct. 15, 2019), which is a continuation ofInternational Patent Application Number PCT/US2017/032494 filed on May12, 2017, which claims priority to U.S. Patent Application No.62/336,115 filed on May 13, 2016, the contents of which are incorporatedherein by reference in their entireties.

TECHNICAL FIELD

The present technology relates generally to spinal implants and spinalalignment systems. In particular, several embodiments of the presenttechnology are related to anteriorly positioned spinal implants forreducing spinal malalignment, such as spondylolisthesis, and spinalarthrodesis and associated systems and methods.

BACKGROUND

Spondylolisthesis is a condition defined by the anterior displacement ofa spinal vertebra or the vertebral column in relation to the inferiorvertebrae. It can be caused by isthmic or degenerative conditions. Forexample, spondylolisthesis can be the result of a congenitalabnormality, joint damage from a trauma, a vertebral stress fracturecaused by overuse of the joint, and/or joint damage caused by aninfection or arthritis. Thus, the condition can affect children, youngadults, and older adults alike. The condition, which is often located inthe lumbar region of the spine, is separated into five grades dependingon the degree of displacement, with Grade 1 referring to the lowestdegree of slippage (0-25%) and Grade 5 referring to the highest degreeof slippage (over 100%). Symptoms can include back pain, buttock pain,pain that runs from the lower back down one or both legs, difficultywalking, and potentially the loss of bladder or bowel control.

Surgical intervention is used when the pain becomes extreme or there isdamage to the nerve root or vertebral column. For example, decompressionprocedures can remove bone or other tissue to reduce pressure from thevertebral column and/or nerves, and spinal fusion procedures can fusethe vertebrae together to stabilize the spine. Posterior approaches(i.e., accessing from the patient's back) that reduce malalignment andstabilize the spine are typically used to correct high-gradespondylolisthesis. However, the posterior approach makes it difficult toaccess the pedicles of the vertebrae, in which alignment screws areplaced to bring the misaligned vertebrae back into proper alignment. Inaddition, posterior approaches carry a risk of neurologic injury. Forexample, studies have shown that 35-40% of posterior surgical reductionprocedures resulted in neurologic deficits and complications.Furthermore, posterior approaches require significant disruption of theback muscles and do not allow for the release of the deforming forcesfrom anterior ligaments because they cannot be appropriately accessedfrom the posterior position. Accordingly, further studies have shownthat more than half of patients who underwent surgical posterior fusiontreatments for spondylolisthesis had fair or poor results.

Spinal arthrodesis (i.e., spinal fusion) can also be provided from ananterior approach. However, current anterior reduction surgery withinterbody fusion has a relatively high chance of failure from loss ofreduction (i.e., further slippage) if not combined with a second stageposterior surgery. To address this shortcoming, anterior fusion devicesgenerally require supplemental fixation from the posterior side of thevertebrae. However, supplemental posterior stabilization is susceptibleto the disruption of back muscles, neural injury, and difficultyaccessing anchor points on the vertebra associated with exclusivelyposterior approaches.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components can be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent. The headings provided herein are forconvenience only.

FIG. 1A is an isometric view of a spinal implant device configured inaccordance with embodiments of the present technology.

FIG. 1B is an isometric view of the spinal implant device of FIG. 1Aimplanted in a vertebral column in accordance with embodiments of thepresent technology.

FIG. 2 is an isometric view of portions of a spinal implant systemincluding the spinal implant device of FIG. 1A and an alignment systemattached thereto during a spinal implant procedure in accordance withembodiments of the present technology.

FIG. 3 is an isometric view of portions of the spinal implant device andthe alignment system of FIGS. 1A-2 during a stage of a spinalrealignment and stabilization procedure in accordance with embodimentsof the present technology.

FIG. 4 is an isometric view of portions of the spinal implant device andthe alignment system of FIGS. 1A-2 during an angular correction stage ofthe spinal realignment and stabilization procedure in accordance withembodiments of the present technology.

FIG. 5A is an isometric view of portions of the spinal implant deviceand the alignment system of FIGS. 1A-2 during an intermediate attachmentstage of the spinal realignment and stabilization procedure inaccordance with embodiments of the present technology.

FIGS. 5B and 5C are top cross-sectional views of a portion of adistraction assembly of the alignment system of FIG. 5A shown before andafter engagement with a shaft of the alignment system, respectively, inaccordance with embodiments of the present technology.

FIG. 6 is an isometric view of portions of the spinal implant device andthe alignment system of FIGS. 1A-2 during a distraction stage of thespinal realignment and stabilization procedure in accordance withembodiments of the present technology.

FIG. 7A is an isometric view of portions of the spinal implant deviceand the alignment system of FIGS. 1A-2 during a linear translation stageof the spinal realignment and stabilization procedure in accordance withembodiments of the present technology.

FIGS. 7B-7D are enlarged isometric views of the spinal implant deviceand the alignment system of FIG. 7A during various stages of lineartranslation and distraction of the spinal realignment and stabilizationprocedure in accordance with embodiments of the present technology.

FIG. 8 is an isometric view of the spinal implant device of FIGS. 1A-2during yet another stage of the spinal realignment and stabilizationprocedure in accordance with embodiments of the present technology.

DETAILED DESCRIPTION

The present technology is generally directed to anterior spinal implantsfor reducing spinal malalignment and spinal arthrodesis and associatedsystems and methods. For example, some embodiments of the presenttechnology are directed to integrated spinal implant systems forreducing malalignment and stabilizing the spine. Specific details ofseveral embodiments of the present technology are described herein withreference to FIGS. 1A-8. Although many of the embodiments are describedwith respect to devices, systems, and methods for reducing the effectsof spondylolisthesis in the lumbar region of the spine, otherapplications and other embodiments in addition to those described hereinare within the scope of the present technology. For example, at leastsome embodiments of the present technology may be useful for correctingspinal malalignment along other portions of the spine, such as thecervical or thoracic spine. In addition, at least some embodiments ofthe present technology may be useful for correcting spinal malalignmentcaused by other conditions, such as degenerative disc disease.

It should be noted that other embodiments in addition to those disclosedherein are within the scope of the present technology. Further,embodiments of the present technology can have different configurations,components, and/or procedures than those shown or described herein.Moreover, a person of ordinary skill in the art will understand thatembodiments of the present technology can have configurations,components, and/or procedures in addition to those shown or describedherein and that these and other embodiments can be without several ofthe configurations, components, and/or procedures shown or describedherein without deviating from the present technology.

With regard to the terms “anterior” and “posterior” within thisdescription, unless otherwise specified, the terms can refer to relativepositions of portions of a spinal implant device and/or an associatedalignment system with reference to the spine or individual vertebra of apatient. For example, when referring to spinal implant systems thatalign and/or stabilize a spine, “anterior” or “anteriorly” can refer toa position toward the front of a patient's spine or directed toward thefront of the patient's body (e.g., toward a forward-facing portion ofthe body of a vertebra or toward the patient's abdomen), and “posterior”or “posteriorly” can refer to a position toward the back of a patient'sspine or directed toward the back of the patient's body (e.g., towardthe spinous process of a vertebra).

With regard to the terms “superior” and “inferior” within thisdescription, unless otherwise specified, the terms can refer to relativepositions of portions of a spinal implant device and/or an associatedalignment system with reference to the spine or individual vertebra of apatient. For example, when referring to spinal implant systems thatalign and/or stabilize a spine, “superior” or “superiorly” can refer toa position relative to a patient's spine closer to the patient's head(e.g., the L4 vertebra is superior to the L5 vertebra), and “inferior”or “inferiorly” can refer to a position relative to the spine toward thepatient's legs.

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can referencerelative positions of portions of a spinal implant device and/or anassociated alignment system with reference to an operator. For example,in referring to an alignment system suitable to deliver and positionvarious spinal implant devices described herein, “proximal” can refer toa position closer to the operator of the alignment system or an incisioninto the patient (e.g., at the patient's abdominal region), and “distal”can refer to a position that is more distant from the operator of thealignment system or further from the incision.

FIG. 1A is an isometric view of a spinal implant device 100 configuredin accordance with embodiments of the present technology, and FIG. 1B isan isometric view of the spinal implant device 100 of FIG. 1A affixed toa vertebral column 101 of a patient in accordance with embodiments ofthe present technology. The spinal implant device 100 includes asuperior or first vertebral support 102 configured to be attached to asuperior or first vertebra 103, an inferior or second vertebral support104 configured to be attached to an inferior or second vertebra 105, anda reinforcement plate 106 extending between and connecting the first andsecond vertebral supports 102 and 104 (collectively referred to as“vertebral supports 102, 104”). The first vertebral support 102 includesa first anterior portion 108 a, a first intervertebral portion 110 aextending in a generally transverse manner from the first anteriorportion 108 a, and a first engagement feature 112 a at the firstintervertebral portion 110 a. Similarly, the second vertebral support104 includes a second anterior portion 108 b, a second intervertebralportion 110 b extending in a generally transverse manner from the secondanterior portion 108 b, and a second engagement feature 112 b at thesecond intervertebral portion 110 b. As shown in FIG. 1B, the first andsecond anterior portions 108 a and 108 b (referred to collectively as“anterior portions 108”) can attach to anterior regions of thecorresponding superior and inferior vertebrae 103 and 105, and the firstand second intervertebral portions 110 a and 110 b (referred tocollectively as “intervertebral portions 110”) extend from thecorresponding anterior portions 108 in a posterior direction such thatthey are position in the intervertebral or interbody space between thesuperior and inferior vertebrae 103 and 105. When the vertebral supports102, 104 are correctly aligned relative to each other, the first andsecond engagement features 112 a and 112 b (referred to collectively as“engagement features 112”) can interlock within the interbody space. Theinterlocking engagement features 112 and the additional support providedby the anterior plate 106 are expected to maintain and stabilize thefirst and second vertebrae 103 and 105 relative to each other after arealignment procedure.

As shown in FIGS. 1A and 1B, the anterior portions 108 of the vertebralsupports 102, 104 each include at least one vertebral attachment hole oraperture 114 (identified individual as first vertebral attachment holes114 a and second vertebral attachment holes 114 b) and at least oneplate attachment hole or aperture 116 (identified individually as afirst plate attachment hole 116 a and a second plate attachment hole 116b). The vertebral attachment holes 114 receive screws 1 18 that affixthe vertebral supports 102, 104 to the corresponding superior andinferior vertebrae 103 and 105, and the plate attachment holes 116receive screws 118 that affix the anterior plate 106 to the vertebralsupports 102, 104 and, optionally, to the adjacent vertebra. Forexample, the vertebral attachment holes 114 and the plate attachmentholes 116 can be configured to receive bone screws having a diameter of6 mm (0.236 inch). In some embodiments, the vertebral and plateattachment holes 114 and 1 16 can have other suitable dimensions forreceiving screws and/or other fasteners that can attach the vertebralsupports 102, 104 to the vertebrae and to the anterior plate 106. Asshown in FIGS. 1A and 1B, the anterior portion 108 of each vertebralsupport 102, 104 can include two vertebral attachment holes 114 (e.g.,as shown in FIGS. 1A and 1B) and one plate attachment hole 1 16. Invarious embodiments, the anterior portions 108 may each include a singlevertebral attachment hole 114, more than two vertebral attachment holes114, more than one plate attachment hole 116, and/or the first anteriorportion 108 a can include a different number of vertebral and fixationattachment holes 114 and 116 than the second anterior portion 108 b. Insome embodiments, the vertebral supports 102, 104 can be affixed to thevertebrae using other mechanisms for attaching implants to bone, and/orthe anterior plate 106 can be affixed to the vertebral supports 102, 104using other mechanisms for attaching two portions of an implanttogether.

As shown in FIG. 1B, the vertebral attachment holes 114 can have anangled surface for receiving the screws 1 18 such that the screws 118extend into the adjacent vertebral bone at an angle to providebicortical bone attachment. For example, the first vertebral attachmentholes 114 a can have an incline angle of about 25°, and the secondvertebral attachment holes 114 b can have a decline angle of about 25°.When the screws 118 enter the bone at the angle provided by thevertebral attachment holes 114, the screws 118 can extend into orthrough two portions of the cortical bone: one portion adjacent to theanterior portion 108 of each vertebral support 102, 104 and one portionadjacent to the intervertebral portion 110 of each vertebral support102, 104. In various embodiments, the vertebral supports 102, 104 caninclude recesses or apertures in the surfaces of the intervertebralportions 110 facing the associated superior or inferior vertebra toguide the screws 118 into bicortical attachment. For example, as shownin FIG. 1A, a superiorly-facing surface 134 of the first intervertebralportion 110 a (i.e., the surface that contacts an inferiorly-facingsurface of the superior vertebra 103 (FIG. 1B)) includes at least oneaperture or recess 125 sized and shaped to an receive end portion of ascrew 118 (FIG. 1B) after the screw 118 passes through a portion of thecortical bone of the superior vertebra 103 proximate to the interbodyspace. Similarly, the inferiorly-facing surface of the secondintervertebral portion 110 b can include one or more recesses orapertures (not visible) sized and shaped to receive the end portions ofcorresponding screws 118 (FIG. 1B) after the screws pass through thecortical bone of the inferior vertebra 105 proximate to the interbodyspace. This bicortical fixation is expected to enhance the fixation ofthe vertebral supports 102, 104 to the corresponding vertebra and resistaxial forces applied to the screws 118. In some embodiments, the angleof entry provided by the vertebral attachment holes 114 can be larger orsmaller to accommodate bicortical bone attachment. In variousembodiments, the plate attachment holes 116 can also be configured toreceive the screws 1 18 at an angle to provide for bicortical attachmentand resist axial forces.

Referring to FIG. 1A, the intervertebral portions 110 of the vertebralsupports 102, 104 can also include interbody openings 120 (identifiedindividually as a first interbody opening 120 a and a second interbodyopening 120 b) that extend through the thickness of the intervertebralportions 110. These interbody openings 120 can facilitate subsequentbone fusion between the adjacent vertebrae when bone graft has beeninserted into the interbody space during an implantation procedure. Insome embodiments, for example, each interbody opening 120 can be about10 mm in width and 17 mm in length. In various embodiments, theinterbody openings 120 can have other suitable dimensions for receivingbone graft and facilitating bone fusion. In some embodiments, eachintervertebral portion 110 can have more than one interbody opening 120and/or other features that facilitate bone fusion. For example, thefirst vertebral support 102 can include side windows 122 on the lateralsides of the first intervertebral portion 110 a to facilitate bonegrowth through the lateral sides of the implant in addition to axialbone growth. In various embodiments, the second vertebral support 104can also include side windows similar to those of the first vertebralsupport 102. In some embodiments, the first vertebral support 102 and/orthe second vertebral support 104 include posterior openings 124extending through posterior regions of the intervertebral portions 110and configured to facilitate bone growth in a posterior direction fromthe implant device 100.

As further shown in FIGS. 1A and 1B, the engagement features 112 of thetwo vertebral supports 102, 104 can be interlocking protrusions orledges 126 (identified individually as first ledges 126 a and secondledges 126 b) extending outwardly from the intervertebral portions 110into the interbody space between adjacent vertebrae. The firstengagement feature 112 a includes two laterally spaced apart firstledges 126 a, and each first ledge 126 a includes a first lip surface128 a curved or angled in a generally anterior direction to form aflange. The second engagement features 112 b includes two laterallyspaced apart second ledges 126 b, and each second ledge 126 b includes asecond lip surface 128 b curved or angled in a generally posteriordirection to form a recess such that the first and second lip surfaces128 a and 128 b (identified collectively as “lip surfaces 128”)interface with each other when the first and second vertebral supports102 and 104 are aligned. For example, each first ledge 126 a can have agenerally Z-shaped cross-section in which the anteriorly projectingflange of the “Z” engages with the posteriorly directed recess of thecorresponding second ledge 126 b. The surfaces of the ledges 126 can befilleted or curved as shown in FIGS. 1A and 1B, or they may be definedby straight intersecting surfaces. In some embodiments, the first ledges126 a are formed by intersecting surfaces having an angle less than 90°such that the first ledges 126 a can be positioned within and overlapwith the corresponding second ledges 126 b. For example, the first lipsurface 128 a and a posterior, inferiorly-facing surface 130 of thefirst ledge 126 a can form an angle of about 50-55°, or the surfaces 128a and 130 can define a different angle relative to each other to matewith the corresponding second ledges 126 b. The angled first ledges 126a enhance engagement between the corresponding first and second ledges126 a and 126 b and inhibit slippage therebetween, such is when aforward bending moment is applied to the first vertebral support 102(e.g., caused by the vertebrae attempting to shift duringspondylolisthesis relapse). In some embodiments, the lip surfaces 128and/or the ledges 126 can have other suitable complimentary dimensions.In some embodiments, each vertebral support 102, 104 can include asingle ledge 126 (e.g., extending across the width of the intervertebralportion 110) or more than two ledges 126 that interface with acorresponding number of ledges 126 on the opposing vertebral support102, 104. In various embodiments, the engagement features 112 can havedifferent types of interlocking surfaces and/or different features foraffixing the first vertebral support 102 to the second vertebral support104 when the two vertebral supports 102, 104 are properly aligned.

In some embodiments, the second intervertebral portion 110 b of thesecond vertebral support 104 has an anteriorly-facing surface 132extending posteriorly in an obtuse angle from the second anteriorportion 108 b. For example, the second anterior portion 108 b and theanteriorly-facing surface 132 can define an angle of 115-135° and/orother suitable obtuse angles. This angled arrangement of the secondintervertebral portion 110 b can assist in the linear translation (e.g.,movement along the posterior-anterior axis, transverse to the axis ofthe spine 101; also referred to as “horizontal movement”) of the firstvertebral support 102 relative to the second vertebral support 104.During an alignment procedure, for example, the poster-facing surface(s)of the first vertebral support 102 can glide along the angledanteriorly-facing surface 132 of the second vertebral support 104 as thesuperior vertebra moves in a posterior direction during lineartranslation.

The first and second vertebral supports 102 and 104 can be sized andshaped to accommodate the native spinal anatomy to provide properalignment between adjacent vertebrae. For example, the inwardly surfacesof the first and second vertebrae 103, 105 that attach to intervertebralportions 110 of the vertebral supports 102, 104 are not typicallyparallel to each other even when properly aligned and, therefore, thespinal implant device 100 can be shaped to accommodate the angletherebetween. For example, the natural angle between the interbodysurfaces of the L5 and L4 vertebrae is typically about 8°. Accordingly,the first and second intervertebral portions 110 a and 1 10 b can besized and shaped such that, when the engagement features 112 interlock,the surface of the first intervertebral portion 110 a facing thesuperior vertebra 103 and the surface of the second intervertebralportion 1 10 b facing the inferior vertebra 105 form an angle of about8° relative to each other. When the spinal implant device 100 is used torealign vertebrae having different natural angles relative to eachother, the first and second vertebral supports 102 and 104 can beconfigured to accommodate the appropriate native angle.

With reference to FIG. 1A, the angled arrangement between the first andsecond vertebral supports 102 and 104 can be achieved by imparting anangle on the overall structure of first intervertebral portion 110 a,while the second intervertebral portion 110 b does not have such anangled configuration. For example, the superior-facing surface 134 ofthe first intervertebral portion 110 a (i.e., the surface that contactsan inferiorly-facing surface of the superior vertebra 103 (FIG. 1B)) andthe face of the first intervertebral portion 110 a that contacts theopposing portions of the second intervertebral portion 110 b of thesecond vertebral support 104 can define an angle θ relative to eachother generally corresponding or related to the angle between theintervertebral portions of the adjacent vertebrae. The overall angle θof the first intervertebral portion 110 a can be 8°, 10°, 13°, and/orother suitable angles to accommodate the native anatomy. In contrast,the structure of the second intervertebral portion 110 b does not havean angle because the inferior-facing surface of the secondintervertebral portion 110 b and the face of the second intervertebralportion 110 b that contacts the opposing portions of the firstintervertebral portion 110 a are generally parallel. Thus, toaccommodate the native anatomy of a patient, the first vertebral support102 is selected or designed to have an overall angle generally similarto the angle of the native anatomy of the aligned adjacent vertebrae,while the same standard second vertebral support 104 can be usedregardless of the angle of the native anatomy. This arrangement of thefirst and second vertebral supports 102 and 104 allows manufacturers toprovide first vertebral supports 102 with different overall structuralangles that pair with a single configuration of the second vertebral 104and, therefore, reduces the total number of parts stored for spinalimplant procedures. In various embodiments, the second vertebral support104, rather than the first vertebral support 102, can be the one toprovide the overall angle to the spinal implant device 100, or both thefirst and second vertebral supports 102 and 104 can have an overallangle that provides the desired angle between the vertebral supports102, 104.

The vertebral supports 102, 104 can have generally similar dimensions tofacilitate delivery to the displaced vertebrae while providingsufficient support to stabilize the vertebrae in the desired positiononce aligned. For example, the anterior portions 108 can have dimensionsto limit the amount of vertebra that needs to be exposed to affix thevertebral supports 102, 104 to the vertebrae. In some embodiments, forexample, the anterior portions 108 can extend superiorly or inferiorlyalong the anterior face of the corresponding vertebra a distance ofabout 13 mm (0.512 inch), an overall height of 15 mm (0.591 inch), and amediolateral width of about 28 mm (1.102 inch). The anterior portions108 can be relatively thin to avoid protruding anteriorly into theabdominal cavity while maintain adequate strength, such as about 2 mm(0.079 inch) in thickness. The intervertebral portions 110 can have alength that facilitates fusion between the superior and inferiorvertebrae 103, 105 through the intervertebral space, while not extendingso far as to avoid the cauda equina and/or peripheral nerves. Forexample, the intervertebral portions 110 can have a length (extendingposteriorly from the anterior portions 108) of about 22 mm (0.866 inch).In other embodiments, the vertebral supports 102, 104 can have othersuitable dimensions based on the patient's anatomy and/or the dimensionsrequired to maintain sufficient support post-operatively.

The vertebral supports 102, 104, as well as the anterior plate 106 canbe made from titanium, titanium alloys (e.g., Ti6Al4V), cobalt-chromemolybdenum alloys, stainless steel, and/or other medical grade materialssuitable for implants in the body. These components can me manufacturedusing 3-D printing, molding, and/or other suitable manufacturing methodsfor creating implants.

As discussed above, the anterior plate 106 can extend between theanterior portions 108 of the first and second vertebral supports 102 and104 to secure the two vertebral supports 102, 104 together when aligned.Accordingly, the anterior plate 106 can have an axial height extendingalong the entire height of the anterior portions 108 of both the firstand second vertebral supports 102 and 104, a mediolateral width thatextends along the entire width of the vertebral supports 102, 104, andan overall angle or curvature corresponding to the angle between thefirst and second vertebral supports 102 and 104. For example, theanterior plate 106 may have an overall height of about 38.384 mm (1.117inch), a mediolateral width of about 28 mm (1.102 inch), and an overallangle of about 8° in a posterior direction between superior and inferiorportions of the anterior plate 106. The anterior plate 106 can also berelatively thin such that the overall thickness of the plate and theanterior portions 108 of the vertebral supports 102, 104 protrudeanteriorly only a relatively small distance, such as about 3.5 mm (0.138inch) in overall thickness. In some embodiments, the anterior plate 106has a different height, only extends along portions of the first andsecond anterior portions 108 a and 108 b of the vertebral supports 102,104, has a different angle associated with the native spinal anatomy,and/or is made of a sufficiently flexible material and/or includesfeatures (e.g., thinned transverse sections) that allow the anteriorplate 106 to bend and flex to accommodate the shape of the vertebralsupports 102, 104 relative to each other. The anterior plate 106includes attachment holes 136 (identified individually as a firstattachment hole 136 a and a second attachment hole 136 b) that alignwith corresponding plate attachment holes 1 16 of the first and secondvertebral supports 102 and 104 and are configured to receive screws 118and/or other shafts that secure the anterior plate 106 and the vertebralsupports 102, 104 together. The screws 118 that attach the anteriorplate 106 to the vertebral supports 102, 104 can be longer than thescrews 118 for the vertebral supports 102, 104 to accommodate theadditional thickness of the anterior plate 106. For example, the screws118 can be 25 mm (0.984 inch) in length. In other embodiments, theanterior plate 106 can attach to the vertebral supports 102, 104 usingother suitable attachment means.

As further shown in FIGS. 1A and 1B, the anterior plate 106 can includea window 138 that allows a physician (e.g., a surgeon) to place bonegraft material into the interbody space to facilitate fusion between theadjacent vertebrae. For example, the window 138 can have dimensions of 8mm (0.315 inch) in height and 14 mm (0.551 inch) in width. In someembodiments, the window 138 can have larger or smaller dimensionsdepending upon the sizing of the vertebral supports 102, 104 and/or thenative anatomy.

After implantation, the spinal implant device 100 is configured towithstand the forces in vivo to maintain the reduction. That is, thespinal implant device 100 can be configured to maintain 0° of rotationbetween the adjacent vertebrae and 0 mm of horizontal and verticaltranslation in vivo. For example, the spinal implant device 100 isexpected to withstand 1.99 kN force in the anterior direction to avoidspondylolisthesis relapse, a 6.6 Nm torsion moment, a 15 Nm moment inflexion and extension from fatigue loading, and a 2.4 kN axial load fromanatomical loading.

FIG. 2 is an isometric view of a spinal implant system 200 includingportions of the spinal implant device 100 of FIG. 1A and an alignmentsystem 202 attached thereto during a spinal implant procedure inaccordance with embodiments of the present technology. The alignmentsystem 202 includes a superior attachment component 204 that releasablyattaches to the first vertebral support 102, an inferior attachmentcomponent 206 that releasably attaches to the second vertebral support104, and a distraction assembly 208 operably coupled to the superiorattachment component 204 and the inferior attachment component 206. Thecomponents of the alignment system 202 extend in an anterior directionfrom the vertebral supports 102, 104 such that the alignment system 202can be attached to the spinal implant device 100 and manipulated from apurely anterior approach. The alignment system 202 is configured toprovide angular correction, vertical displacement (i.e., “distraction”),and posterior linear translation of adjacent superior and inferiorvertebrae relative to each other to realign the two vertebrae, andthereby allow the first and second vertebral supports 102 and 104 toengage each other to maintain the realigned position of the vertebrae.

As shown in FIG. 2, the superior attachment component 204 is releasablycoupled to the first anterior portion 108 a of the first vertebralsupport 102. The superior attachment component 204 can include asuperior shaft 210 (shown in broken lines) with a distal end portionthat threadably engages the first plate attachment hole 116 a of thefirst vertebral support 102, and a superior tube 212 that extends overthe superior shaft 210 and is movable (e.g., slidable) relative to thesuperior shaft 210. In some embodiments, the superior shaft 210 caninclude other attachment mechanisms for releasably attaching thesuperior shaft 210 to the first anterior portion 108 a and/or otherportions of the first vertebral support 102. The superior tube 212 has adistal end portion 214 a configured to be positioned adjacent to thefirst anterior portion 108 a of the first vertebral support 102 and aproximal end portion 214 b opposite the distal end portion 214 a. Thedistal end portion 214 a of the superior tube 212 can include at leastone hole (not visible) that allows for releasable attachment to thedistraction assembly 208. The proximal end portion 214 b of the superiortube 212 can include an engagement feature 216 that operably couples thesuperior tube 212 to a linear translation driver 218, which can be usedto horizontally displace the superior vertebra 103 relative to theinferior vertebra 105 during an alignment procedure. For example, theengagement features 216 can be internal threads positioned within theproximal end portion 214 b of the superior tube 212, and the lineartranslation driver 218 can include a shaft 220 with a threaded portionthat engages the internal threads when rotated within the superior tube212. As described in further detail below, applying torque to the lineartranslation driver 218 (e.g., via a handle 222 connected to a proximalportion of the shaft 220) causes a distal end of the shaft 220 of thelinear translation driver 218 to press against the proximal end portionof the superior shaft 210 and drive the superior shaft 210 in aposterior direction that, in turn, drives the first vertebral support102 and the superior vertebrae 103 attached thereto in the posteriordirection. In various embodiments, the linear translation driver 218 canbe operably coupled to the superior tube 212 using other suitableattachment means and/or may include other mechanisms that drive thefirst vertebral support 102 in the posterior direction. For example, thelinear translation driver 218 can include a piston mechanism to impartposterior linear translation on the superior shaft 210 and the firstvertebral support 102 coupled thereto.

The inferior attachment component 206 is releasably coupled to thesecond anterior portion 108 b of the second vertebral support 104.Similar to the superior attachment component 204, the inferiorattachment component 206 can include an inferior shaft 224 thatthreadably engages the second plate attachment hole 116 b of the secondvertebral support 104. In some embodiments, the inferior shaft 224 caninclude attachment mechanisms for releasably attaching the inferiorshaft 224 to the second anterior portion 108 b and/or other portions ofthe second vertebral support 104. The inferior shaft 224 can alsoinclude a plurality of holes 226 extending along its length that allowfor attachment to the distraction assembly 208.

The distraction assembly 208 includes a superior distraction component228 a configured to releasably couple to the superior attachmentcomponent 204 via a first coupling mechanism 232 a, an inferiordistraction component 228 b configured to releasably couple to theinferior attachment component 206 via a second coupling mechanism 232 b,and a distraction member 230 extending between the superior and inferiordistraction components 228 a and 228 b (referred to collectively as“distraction components 228”). In some embodiments, the first and secondcoupling mechanisms 232 a and 232 b (referred to collectively as“coupling mechanisms 232”) can be plunger connectors that interact withthe holes 226 in the inferior shaft 224 and the superior tube 212 tolock the distraction components 228 in place relative to each other. Forexample, as described in further detail below, the superior distractioncomponent 228 a can slide over the superior tube 212 and, when thesuperior plunger connector aligns with the hole on the distal portion214 a of the superior tube 212, a spring or other biasing member candrive the superior plunger connector into the hole to lock the superiordistraction component 228 a into place relative to the superior tube212. Similarly, the inferior distraction component 228 b can slide overthe inferior shaft 224 with the inferior plunger pulled outwardly (i.e.,away from the inferior shaft 224) and, when the inferior distractioncomponent 228 b generally aligns the superior distraction component 228a (along an axis extending inferiorly from the superior distractioncomponent 228 a), the inferior plunger can be released such that thebiasing member drives the inferior plunger connector into thecorresponding hole 226 along the inferior shaft 224 to lock the inferiordistraction component 228 b into place relative to the inferior shaft224. In other embodiments, the coupling mechanisms 232 can include othersuitable attachment mechanisms to attach the distraction components 228to distal portions of the superior and inferior attachment components204 and 206, such as threaded engagement features, interfacing surfaces,pressurized attachment mechanisms, and/or interlocking surfaces.

The distraction member 230 operably couples to the superior and inferiordistraction components 228 a and 228 b such that the distraction member230 can drive the distraction components 228 longitudinally apart fromeach other along an axis extending through the distraction components228. In various embodiments, such as the embodiment illustrated in FIG.2, the distraction member 230 is a threaded shaft or screw 236 thatextends through an inferior threaded hole 234 b of the inferiordistraction component 228 b to a superior threaded hole 234 a of thesuperior distraction component 228 a. A physician (not shown) can applytorque to the head of the screw 236 (positioned at an inferior side ofthe inferior distraction component 228 b) via a distraction driver 238,such as a hex key (i.e., an “Allen wrench”) and/or other type of driverthat can engage with and rotate the screw 238. In some embodiments, thedistraction member 230 itself includes an integrated component that canbe used to rotate the screw 236. Rotating the screw 236 generates asuperiorly-directed force that drives the superior distraction component228 a in a superior direction apart from the inferior distractioncomponent 228 b (along the axis defined by the screw 236). The superiordistraction component 228 a acts on the superior attachment component204, which imparts a superiorly directed force on the first vertebralsupport 102 and the superior vertebra 103 attached thereto to restorevertebral height between the inferior vertebra 105 and the superiorvertebra 103.

In some embodiments, the distraction member 230 can include differentmechanisms positioned between the distraction components 228 andconfigured to vertically translate the distraction components 228 andthe vertebrae coupled thereto relative to each other. For example, thedistraction member 230 may be a notched shaft that drives the superiordistraction component 238 a in the superior direction between thenotches when driven superiorly by a lever, a piston device that pushesthe superior distraction component 238 a superiorly, a jack mechanismthat drives the superior distraction component 238 a in the superiordirection when a lever arm is driven in the inferior direction, a pumpdevice that drives the superior distraction component 238 a in thesuperior direction when an actuator is squeezed, ahydraulically-activated driver that drives the superior distractioncomponent 238 a in the superior direction when fluid is deliveredbetween the distraction components 228, and/or other suitable componentsto distract the superior vertebra 103 from the inferior vertebra 105.

In operation, the spinal implant system 200 can realign and stabilizevertebral segments to treat spondylolisthesis and/or other spinalmalalignment by correcting forward displacement and sagittal rotationdeformities, as well as distract adjacent vertebrae to restoreintervertebral height. The first vertebral support 102 can be attachedto the displaced superior vertebrae 103, and the second vertebralsupport 104 can be attached to the vertebra 105 immediately inferior tothe displaced vertebra 103. For example, lumbar spondylolisthesis oftenoccurs when the L4 vertebra slips anteriorly over the L5 vertebra, andtherefore the first and second vertebral supports 102 and 104 can beattached to the L4 and L5 vertebrae, respectively. The superiorattachment component 204 can then be attached to the first vertebralsupport 102 and the inferior attachment component 206 can be attached tothe second vertebral support 104. A physician can apply torque to thesuperior attachment component 204, such as the superior tube 212, tocorrect the angle of the superior vertebra 103 caused by the deformity.For example, the superior attachment component 204 can be configured towithstand at least 13.75 Nm of torque and adjust the sagittal rotationby at least 30°.

When the distraction assembly 208 is operably coupled to the superiorand inferior attachment components 204 and 206, the physician canmanipulate the distraction member 230 (e.g., by rotating to thedistraction screw 236) to distract the superior and inferior vertebrae103 and 105. For example, the distraction assembly 208 can displace thesuperior and inferior distraction components 228 (and the vertebrae 103,105 attached thereto) by a height of at least 11.2 mm, and the spinalimplant system 200 can be configured to withstand at least 422 N offorce in the superior direction to provide the desired distraction. Withthe vertebrae 103, 105 vertically spaced apart from each other, thephysician can manipulate the linear translation driver 218 (e.g., rotatethe linear translation shaft 220) to move the superior vertebra 103 in aposterior direction back into alignment with the inferior vertebra 105such that the engagement features 112 lock into place in the interbodyspace between the vertebrae 103, 105. For example, the lineartranslation driver 218 and the components coupled thereto can linearlytranslate the superior vertebrae 103 a distance of at least 46.3 mm andwithstand a force of at least 1.99 kN to do so. With the engagementfeatures 1 12 interlocked, the physician can remove the alignment system202 from the vertebral supports 102, 104, and secure the anterior plate106 (FIGS. 1A and 1B) to vertebral supports 102, 104 to reinforce andstabilize the corrected vertebral position. In some embodiments, thecomponents of the spinal implant system 200 can be configured to providelarger or smaller degrees of angular correction, larger or smallervertical displacement, and/or larger or smaller linear displacement,and/or the spinal implant system 200 can be configured to withstandgreater or smaller forces to provide the desired alignment. In variousembodiments, the spinal implant system 200 can be used for only angularcorrection, distraction, or linear alignment depending on the spinaldeformity.

The spinal implant system 200 is expected to provide an integratedsystem for realigning and stabilizing vertebrae using an anteriorapproach and anterior fixation. In various embodiments, for example, thespinal implant system 200 can correct Grade I-V spondylolisthesisdeformities from the anterior side of the spine. This purely anteriorapproach and stabilization is not subject to the neurologiccomplications and disruption of back muscles associated with systemsthat rely on posterior access and/or posterior fixation. Further, theanterior approach allows the physician to directly visualize theherniated disc, tightened ligaments, and/or other reactive anatomicalchanges that occur in an attempt to stabilize the spine or as a resultof the misaligned vertebrae. Accordingly, the physician can readilyperform a discectomy and/or release the tightened anatomical structures(e.g., the anterior longitudinal ligament) from the anterior positionbefore or during an alignment and implantation procedure. Aftercorrecting the spinal malalignment and restoring trunk height with thealignment system 202, the spinal implant device 100 is expected toprovide standalone anterior fixation for Grade I-V spondylolisthesisdeformities to maintain the vertebral alignment without the need forsupplemental posterior fixation. Further, the sizing of the vertebralsupports 102, 104 and the anterior plate 106 (FIGS. 1A and 1B) have asmall mediolateral width relative to other spinal implants and,therefore, require a smaller incision and less exposed vertebral spacefor implantation. The spinal implant device 100 is also expected toleave significant surface area of the vertebrae in the interbody spaceexposed (e.g., via the intervertebral openings 120, side windows 122,and posterior openings shown in FIG. 1A) and, therefore, facilitateshigh fusion rates between the adjacent vertebrae and enhance vertebralstabilization postoperatively. In addition, the alignment system 202 isconfigured such that all the forces necessary to realign displacedvertebrae and restore trunk height can be provided manually and withoutsubstantial strain on the physician. For example, the superiorattachment component 204 provides a lever arm that increases the momenton the vertebra for angular correction, and the threads of thedistraction assembly 208 and the linear translation driver 218 canovercome deforming forces for distraction and linear translation.

Furthermore, the spinal implant system 200 has modular components thatcan be assembled within the patient during a surgical procedure, whichis expected to provide flexibility based on the constraints on thenative anatomy. For example, the modular spinal implant device 100 canbe assembled and locked together within the patient. Differently shapedor sized vertebral supports 102, 104 and/or components of the alignmentsystem 202 can also be selected intraoperatively to appropriately alignand stabilize the spine. In various embodiments, portions of the spinalimplant system 200 can be preassembled before implantation and/oralignment to expedite the procedure. For example, the first vertebralsupport 102 can be attached to the superior attachment component 204and/or portions thereof before implantation of the first vertebralsupport 102, the second vertebral support 104 can be attached to theinferior attachment component 206 and/or portions thereof beforeimplantation of the second vertebral support 104, the superior andinferior distraction components 228 a and 228 b can be pre-attached tothe distraction member 230 before attaching them to the superior andinferior attachment components 204 and 206, the inferior distractioncomponent 228 b can be pre-attached to the distraction member 230 beforeconnecting the inferior distraction component 228 b to the inferiorshaft 224, and/or other portions of the spinal implant system 200 can bepreassembled.

FIGS. 3-8 illustrate various stages of a realignment and stabilizationprocedure using the spinal implant system 200 described above. Forexample, FIG. 3 is an isometric view of portions of the spinal implantdevice 100 and the alignment system 202 during a stage of therealignment and stabilization procedure in accordance with embodimentsof the present technology. To begin the realignment and stabilizationprocedure, a physician first makes an incision in a patient's abdomen,side, or other location anterior to the patient's vertebral column 101to access and expose anterior portions of the misaligned vertebrae. Thiscan be done using a retroperitoneal or transperitoneal approach. Theincision can be relatively short in length and the and the exposedportions of the vertebrae can be relatively short in height because thefirst and second vertebral supports 102 and 104 can be delivered andattached separately and are designed such that the anterior portions 108only extend along a portion of the overall height of the vertebrae. Forexample, the faces of the anterior portions 108 may be configured suchthat they do not extend past the midpoint of the height of the averageL5 vertebra of an adult male (e.g., about 13 mm (0.512 inch)). Unlikeposterior approaches, from the anterior vantage point, the physician candirectly visualize the reactive anatomical structures holding thedeformity, and can delicately release those reactive structuressurrounding the displaced vertebrae (e.g., by cutting or otherwisereleasing ligaments). The physician can also perform a discectomy toremove the herniated disc material presses on a nerve root or spinalcord between the misaligned vertebrae, which is aided by the anteriorvisualization of the disc space.

After the vertebral space is adequately exposed and the desiredstructures released or removed, the physician can affix the firstvertebral support 102 to the superior vertebra 103 along themediolateral midline of the vertebral body using the screws 118 thatpass through the lateral first holes 114 a on the first anterior portion108 a of the first vertebral support 102. The screws 1 18 can be angledin an inferior direction such that they pass through two portions of thecortical bone of the superior vertebra 103 to enhance fixation. Thephysician can also affix the second vertebral support 104 to theinferior vertebra 105 along the mediolateral midline of the vertebralbody using the screws 118 that are angled in a superior directionthrough the lateral second holes 114 b on the second anterior portion108 b of the second vertebral support 104 to provide bicortical fixationof the second vertebral support 104. In some embodiments, the screws 118are not angled superiorly or inferiorly and/or do not provide bicorticalfixation. In various embodiments, the second vertebral support 104 maybe affixed to the inferior vertebra 105 during a subsequent stage of theprocedure, such as after angular correction of the superior vertebra103.

After the first vertebral support 102 has been attached to the superiorvertebra 103, the superior shaft 210 can be releasably attached (e.g.,via threaded engagement with the first plate attachment hole 116 a) tothe first vertebral support 102. The superior tube 212 can then slideover the superior shaft 210. As shown in FIG. 3, the distal end portion214 a of the superior shaft 210 can include a plurality of holes 240positioned around its circumference, which can be configured tointerface with the subsequently attached superior distraction component228 a (FIG. 2).

As shown in FIG. 4, once the superior tube 212 is in place, thephysician can apply torque to the superior tube 212 (as indicated byarrow A) to correct the angle of the superior vertebra 103. The superiortube 212 serves as a lever arm to provide a greater mechanical advantageto the physician while correcting the angle of the displaced vertebra103.

FIG. 5A is an isometric view of a subsequent stage of the spinalrealignment and stabilization procedure in accordance with embodimentsof the present technology. At this stage, the inferior shaft 224 of theinferior attachment component 206 is releasably attached (e.g., viathreaded engagement with the second plate attachment hole 116 b) to thesecond vertebral support 104. In various embodiments, the inferior shaft224 can act as a lever arm to adjust the angle of the inferior vertebra105 in a similar manner as the superior attachment component 204.

The distraction assembly 208 can then be coupled to the superior andinferior attachment components 204 and 206. The physician can slide thesuperior distraction component 228 a over the superior tube 212, andslide the inferior distraction component 228 b over the inferior shaft224. The superior distraction component 228 a is locked in positionalong the superior tube 212 via the first coupling mechanism 232 a. Whenthe first coupling mechanism 232 a is a plunger connector (e.g., asshown in FIG. 5A), the physician can pull a plunger cap outwardly as thesuperior distraction component 228 a slides along the superior tube 212until the superior distraction component 228 a aligns with one of theholes 240 (FIGS. 3 and 4) in the superior tube 212. At this time, thephysician can then release the plunger cap, which drives the plungerinto the hole 240 to lock the superior distraction component 228 a inplace. The inferior distraction component 228 b can be locked to theinferior attachment component 206 in a similar manner.

FIGS. 5B and 5C, for example, are top cross-sectional views illustratingadditional detail of the inferior distraction component 228 b with thesecond coupling mechanism 232 b before and after engagement with theinferior shaft 224, respectively, in accordance with embodiments of thepresent technology. The second coupling mechanism 232 b can include aplunger housing 550, a plunger 552 having a head portion 554 positionedwithin the plunger housing 550 in a non-engaged state (FIG. 5B), aplunger cap 556 operably coupled to the plunger 552 and accessible tothe physician, and a spring 558 acting on the head portion 554 of theplunger 552. In operation, the physician can pull the plunger cap 556outwardly from the plunger housing 550 (in the direction of arrow B)while the inferior distraction component 228 b slides along the inferiorshaft 224 (FIG. 5B). Once the second coupling mechanism 232 b is alignedwith the desired hole 226 along the inferior shaft 224 (e.g., when thesuperior and inferior distraction components 228 a and 228 b aregenerally aligned), the physician can release the plunger cap 556. Asshown in FIG. 5C, this allows the spring 558 to decompress and act onthe head portion 554 of the plunger 552 to drive the plunger 552 intothe adjacent hole 226 of the inferior shaft 224, thereby locking theinferior distraction component 228 b in place. The first couplingmechanism 232 a can operate in a similar manner as the second couplingmechanism 232 b shown in FIGS. 5B and 5C. In some embodiments, thedistraction components 228 can be secured to the superior and inferiorattachment components 204 and 206 using other suitable means.

With the superior and inferior distraction components 228 a and 228 blocked in place, the distraction member 230 can be coupled between thedistraction components 228. As shown in FIG. 5 A, for example, thedistraction screw 236 can be threaded through the inferior threaded hole234 b of the inferior distraction component 228 b and then threadedthrough the superior threaded hole 234 a of the superior distractioncomponent 228 a. In some embodiments, the distraction member 230 can bepre-attached to the inferior distraction component 228 b before theinferior distraction component 228 b is attached to the inferiorattachment component 206.

As shown in FIG. 6, once the distraction assembly 208 is in place, thephysician can insert the distraction driver 238 (e.g., a hex key) intothe head of the distraction screw 236 and apply torque to thedistraction driver 238 (as indicated by arrow C). This spins thedistraction screw 236, which translates the superior distractioncomponent 228 a and the superior vertebra 103 coupled thereto in thesuperior direction (as indicated by arrow D) to correct intervertebralheight. That is, the distraction assembly 208 can drive the superiorvertebra 103 superiorly to space the superior and inferior vertebra 103and 105 vertically apart from each other. This spacing restores thetrunk height of the vertebral column 101 and allows for subsequentlinear translation of the vertebrae 103, 105 relative to each otheralong the posterior-anterior axis. In addition, the anterior distractionof the vertebrae 103, 105 opens up the space between the two vertebrae103, 105 in manner that protects the adjacent nerves (e.g., the L5nerve) rather than stretching or compressing the nerve as often occurswith posterior approaches. In some embodiments, the distraction screw236 is manipulated from the opposite side as shown in FIG. 6 (i.e., froma position proximate to the superior distraction component 228 a). Invarious embodiments, the distraction member 230 and/or the distractiondriver 238 can be something other than a screw and wrench thatvertically translate the adjacent vertebrae relative to each other, suchas a jack mechanism, a piston, a pump, and/or other suitable devices.

Once intervertebral height has been restored, the spinal implant system200 can be used to linearly translate the adjacent vertebrae 103, 105.FIG. 7 A, for example, is an isometric view of the spinal implant system200 during a linear translation stage of the spinal realignment andstabilization procedure in accordance with embodiments of the presenttechnology. During linear translation, the linear translation driver 218is attached to the superior tube 212 by inserting the linear translationdriver 218 into the superior shaft 210 and threading the threaded shaft220 into engagement with internal threads 216 (FIGS. 2-5 A) of thesuperior tube 212. Torque is applied to the linear translation driver218 via the T-handle 222 (as indicated by arrow E) rotate the lineartranslation driver 218 further into the superior tube 212. This causesthe distal end of the linear translation driver 218 to apply forceagainst the superior shaft 210 (FIGS. 2 and 3) within the superior tube212, which in turn transmits a force to the first vertebral support 102and the superior vertebra 103 attached thereto (as indicated by arrowF), driving the first vertebral support 102 and the superior vertebra103 in a posterior direction.

FIGS. 7B-7D are enlarged isometric views of the spinal implant device100 and the alignment system 202 of FIG. 7A illustrating various stagesof linear translation and distraction. As shown in FIGS. 7B and 7C, asthe vertebral column 101 moves posteriorly, the first vertebral support102 moves posteriorly in relation to the second vertebral support 104.More specifically, the force (indicated by arrow F) drives the firstledges 126 a of the first engagement feature 112 a of the firstvertebral support 102 posteriorly past the second ledges 126 b of thesecond engagement feature 112 b of the second vertebral support 104. Asshown in FIG. 7D, once the first ledges 126 a are appropriately alignedwith the second ledges 126 b, the physician can lower the firstvertebral support 102 to make contact with the inwardly-facing lowersurface of the second vertebral support 104 and engage the ledges 126 byadjusting the distraction height via the distraction assembly 208 (e.g.,via the distraction driver 238 of FIG. 6). In some embodiments, theengagement features 112 of the two vertebral supports 102, 104 canautomatically engage when linearly aligned without adjusting thedistraction height.

In various embodiments, the inferior attachment component 206 caninclude a shaft and tube configuration similar to the superior shaft 210and the superior tube 212 to facilitate angular adjustments of theinferior vertebra 105 and/or allow for linear translation of theinferior vertebra 105 (e.g., if the vertebra was displaced in aposterior direction). In some embodiments, the inferior attachmentcomponent 206 can include a shaft and tube configuration while thesuperior attachment component 204 includes a shaft similar to that ofthe inferior shaft 224. In this embodiment, the inferior attachmentcomponent 206 can be used to provide angular correction and lineardisplacement of the inferior vertebra.

Once the two vertebral supports 102, 104 are in the proper position andthe engagement features 112 are engaged with each other, the physiciancan remove the instruments of the alignment system 202 from the firstand second vertebral supports 102 and 104. For example, the physiciancan remove the distraction assembly 208, the superior attachmentcomponent 204, and the inferior detachment component 206 sequentially asindividual components or simultaneously with two or more componentsstill attached to each other.

FIG. 8 is an isometric view of the spinal implant device 100 during asubsequent stage of the spinal realignment and stabilization procedurein accordance with embodiments of the present technology. With thealignment system 202 is removed, the engagement features 112 of thevertebral supports 102, 104 act as a locking mechanism to maintain thevertebral alignment and restrict the first vertebral support 102 fromslipping anteriorly relative to the second vertebral support 104. Theengaged vertebral supports 102, 104 therefor provide at least temporarystabilization of the adjacent vertebrae 103, 105 before the anteriorplate 106 is attached. As shown in FIG. 8, the anterior plate 106 isplaced over the first and second vertebral supports 102 and 104 andpermanently affixed thereto using screws 1 18 positioned through theattachment holes 136 of the plate 106 and the central plate attachmentholes 116 of the vertebral supports 102, 104. In various embodiments,the screws 118 can be positioned at an angle to provide furtherbicortical fixation of the spinal implant device. Bone graft can then bepacked into the window 138 of the anterior plate 106 as well as adjacentto and surrounding the vertebral supports 102, 104 (e.g., surroundingthe engagement features 112 and the intervertebral portions 110) withinthe intradiscal space to induce spinal fusion postoperatively. In someembodiments, portions of the spinal plant device 100 (e.g., the anteriorportions 108 of the vertebral supports 102, 104) have roughened surfacesto promote blood flow that will establish and promote cellulararthrodesis over time.

This spinal realignment and stabilization procedure corrects the forwarddisplacement and sagittal rotation deformities associated withspondylolisthesis, distracts adjacent vertebrae to restoreintervertebral height, and does so using an anterior approach andfixation from the anterior side. Thus, the spinal realignment andstabilization procedure is not expected to suffer from the samerestrictions and complications associated with posterior approaches andposterior fixation, and benefit from the direct visualization and neuralpreservation provided by the anterior approach. The spinal implantdevice 100 also allows for bone graft insertion for long-termarthrodesis and boney fusion. Further, the spinal implant system 200provides an integrated system that not only realigns vertebrae, but alsostabilizes the vertebrae after realignment. The spinal implant system200 is also modular in that the system 200 allows the spinal implantdevice 100, as well as the alignment system 202, to be assembled withinthe patient during a surgical procedure.

EXAMPLES

Several aspects of the present technology are set forth in the followingexamples.

1. A spinal implant system for patients with spinal malalignment, thesystem comprising:

a first vertebral support configured to be implanted at an anteriorregion of a first vertebra of a patient;

a second vertebral support configured to be implanted at an anteriorregion of a second vertebra of a patient, wherein the second vertebra isinferior to the first vertebra, and wherein the first and secondvertebral supports are configured to extend into and interlock with eachother within an interbody space between the first and second vertebraewhen the first and second vertebral supports are aligned; and

an alignment system configured to operably couple to the first vertebralsupport and to the second vertebral support to adjust angular, vertical,and linear posterior alignment of the first and second vertebraerelative to each other, the alignment system comprising—

a superior attachment component configured to releasably attach to thefirst vertebral support;

an inferior attachment component configured to releasably attach to thesecond vertebral support; and

a distraction assembly configured to be operably coupled to the superiorattachment component and to the inferior attachment component, whereinthe distraction assembly is configured to vertically displace the firstvertebra from the second vertebra.

2. The spinal implant system of example 1 wherein:

the first vertebral support has a first anterior portion configured tobe attached to the anterior region of the first vertebra, a firstintervertebral portion configured to extend in a posterior directionfrom the first anterior portion, and a first engagement feature at thefirst intervertebral portion; and

the second vertebral support has a second anterior portion configured tobe attached to the anterior region of the second vertebra, a secondintervertebral portion configured to extend in the posterior directionfrom the second anterior portion, and a second engagement feature at thesecond intervertebral portion, wherein the first and second engagementfeatures are configured to interlock within the interbody space betweenthe first and second vertebrae.

3. The spinal implant system of example 2 wherein the first engagementfeature includes a first ledge and the second engagement featureincludes a second ledge, and wherein the first and second ledges areconfigured to engage each other when the first and second vertebralsupports are aligned.

4. The spinal implant system of example 2 or 3 wherein:

the superior attachment component is configured to releasably attach tothe first anterior portion of the first vertebral support and extend inan anterior direction from the first anterior support; and

the inferior attachment component is configured to releasably attach tothe second anterior portion of the second vertebral support and extendin the anterior direction from the second anterior support.

5. The spinal implant system of example 4 wherein:

the superior attachment component comprises a superior shaft and a tubeconfigured to receive the superior shaft, the tube having at least afirst hole; and the inferior attachment component comprises an inferiorshaft having a plurality of second holes extending along a length of theinferior shaft.

6. The spinal implant system of example 5 wherein the distractionassembly comprises:

a superior distraction component having a first plunger memberconfigured to couple the superior distraction component to the tube byengaging the first hole; an inferior distraction component having asecond plunger member configured to couple to the inferior shaft byengaging at least one of the second holes; and a distraction memberextending between the superior distraction component and the inferiordistraction component and configured to vertically separate the firstvertebra from the second vertebra.

7. The spinal implant system of example 6 wherein the distraction memberis a threaded shaft, and wherein rotating the threaded shaft separatesthe superior distraction component from the inferior distractioncomponent along an axis extending through the threaded shaft.

8. The spinal implant system of any one of examples 5-7 wherein:

the tube of the superior attachment component includes internal threads;and the alignment assembly further comprises a linear translation driverhaving a threaded shaft configured to couple to the internal threads ofthe tube, wherein the linear translation is configured to linearlytranslate the first vertebra relative to the second vertebra by rotatingthe linear translation driver into further engagement with the internalthreads of the tube.

9. The spinal implant system of any one of examples 1-5 wherein thedistraction assembly comprises:

a superior distraction component configured to couple the superiorattachment component;

an inferior distraction component configured to couple to the inferiorattachment component; and

a distraction member extending between the superior distractioncomponent and the inferior distraction component and configured tovertically translate the first vertebra apart relative to the secondvertebra.

10. The spinal implant system of any one of examples 1-7, furthercomprising a linear translation driver configured to couple to thesuperior support member or the inferior support member, wherein thelinear translation driver is configured to linearly translate the firstvertebra relative to the second vertebra.

11. The spinal implant system of any one of examples 1-10, furthercomprising an anterior reinforcement plate sized and shaped to fixedlyattach to the first vertebral support and the second vertebral support.

12. The spinal implant system of any one of examples 1-11, furthercomprising: a plurality of first screws configured to attach the firstvertebral support to the first vertebra, wherein the first screws extendthrough two separate portions of cortical bone of the first vertebra;and

a plurality of second screws configured to attach the second vertebralsupport to the second vertebra, wherein the second screws extend throughtwo separate portions of cortical bone of the second vertebra.

13. A modular spinal implant system for patients with spinalmalalignment, the system comprising:

a first vertebral support having a first anterior portion configured tobe attached to an anterior region of a first vertebra of a patient, afirst intervertebral portion configured to extend in a posteriordirection from the first anterior portion, and a first engagementfeature at the first intervertebral portion;

a second vertebral support having a second anterior portion configuredto be attached to an anterior region of a second vertebra of the patientadjacent to the first vertebra, a second intervertebral portionconfigured to extend in a posterior direction from the second anteriorportion, and a second engagement feature at the second intervertebralportion, wherein the first and second engagement features are configuredto interlock with each other within an interbody space between the firstand second vertebrae when the first and second vertebral supports arealigned; and

a reinforcement plate configured to connect to the first and secondanterior portions to affix the first and second vertebral supportstogether.

14. The modular spinal implant system of example 13 wherein the firstengagement feature includes a first angled ledge and the secondengagement feature includes a second angled ledge, and wherein the firstand second angled ledges are configured to interface with each other tolock the first and second vertebral supports together when the first andsecond vertebral supports are aligned.

15. The modular spinal implant system of example 13 or 14, furthercomprising: at least one first shaft configured to attach the firstvertebral support to the first vertebra, wherein the at least one firstshaft extends through two separate portions of cortical bone of thefirst vertebra; and

at least a second shaft configured to attach the second vertebralsupport to the second vertebra, wherein the at least one second shaftextends through two separate portions of cortical bone of the secondvertebra.

16. The modular spinal implant system of any one of examples 13-15,further comprising an alignment system configured to be releasablycoupled to the first and second vertebral supports, wherein thealignment system comprises:

a superior attachment component configured to releasably attach to thefirst anterior portion of the first vertebral support;

an inferior attachment component configured to releasably attach to thesecond anterior portion of the second vertebral support, whereinapplying torque to at least one of the superior attachment component andthe inferior attachment component is configured to correct sagittalrotation deformities of the first and second vertebrae relative to eachother;

a distraction assembly configured to be coupled to the superior andinferior attachment components, wherein the distraction assembly ismovable to vertically displace the first vertebra from the secondvertebra; and a linear alignment member configured to be coupled to atleast one of the superior attachment component and the inferiorattachment component, wherein the linear alignment member is movable tolinearly align the first and second vertebrae.

17. The modular spinal implant system of example 16 wherein thealignment system extends in an anterior direction with respect to thefirst and second vertebral supports when the alignment system is coupledto the first and second vertebral supports.

18. The modular spinal implant system of example 16 or 17 wherein thedistraction assembly comprises a distraction component extending betweenthe superior and inferior attachment components, and whereinmanipulating the distraction component is configured to verticallyseparate the first and second vertebral supports.

19. The modular spinal implant system of any one of examples 13-18wherein at least one of the anterior plate, the first vertebral support,and the second vertebral support comprise at least one window configuredto receive bone graft to facilitate arthrodesis between the first andsecond vertebrae.

20. A method for implanting a spinal implant device to treat spinalmalalignment, the method comprising:

affixing a first vertebral support to an anterior portion of a firstvertebra of a patient;

affixing a second vertebral support to an anterior portion of a secondvertebra of the patient adjacent to the first vertebra;

releasably coupling an alignment system to the first and secondvertebral supports;

applying torque to the alignment system to angularly align the firstvertebra with the second vertebra;

manipulating a distraction assembly of the alignment system tovertically translate the first and second vertebrae; and

manipulating a linear alignment member to translate the first vertebrain a posterior direction relative to the second vertebra, wherein thefirst and second vertebral supports interlock with each other when thefirst and second vertebra are aligned.

21. The method of example 20 wherein affixing the first vertebralsupport to the anterior portion of the first vertebra comprises affixinga screw through an anterior portion of the first vertebral support andthrough two spaced apart portions of cortical bone of the firstvertebra.

22. The method of example 20 or 21, further comprising:

decoupling the alignment system from the first and second vertebralsupports; and fixedly attaching an anterior reinforcement plate toanterior portions of the first and second vertebral supports while thefirst and second vertebral supports are interlocked.

23. The method of any one of examples 20-22, further comprisingaccessing the first and second vertebrae from an anterior side via anincision in a patient.

24. The method of any one of examples 20-23, further comprisingreleasing, from an anterior position relative to the first and secondvertebrae, native structures proximate to the first and second vertebraeholding malalignment of the first and second vertebrae in place.

25. The method of any one of examples 20-24, further comprising removingabnormal disc space between the first and second vertebrae from ananterior position relative to the first and second vertebrae.

26. The method of any one of examples 20-25 wherein releasably couplingthe alignment system to the first and second vertebrae comprises:

releasably coupling a first attachment component to the first vertebralsupport;

releasably coupled a second attachment component to the second vertebralsupport, wherein the first and second attachment components extend in ananterior direction from the first and second vertebral supports.

27. The method of example 26 wherein applying torque to the alignmentsystem to angularly align the first and second vertebrae comprisesapplying torque to the first attachment component.

28. The method of example 26 or 27 wherein manipulating the distractionassembly of the alignment system to vertically translate the first andsecond vertebrae comprises rotating a screw extending between andoperably coupled to the first and second attachment components todistract disc space between the first and second vertebrae.

29. The method of any one of examples 26-28 wherein manipulating thelinear alignment member to translate the first vertebra in the posteriordirection comprises applying torque to the linear alignment member asthe linearly alignment member is engaged with the first attachmentfeature such that the first attachment feature drives the firstvertebral support in the posterior direction.

30. The method of any one of examples 20-29, further comprisingmanipulating the distraction assembly of the alignment system tovertically translate the first and second vertebrae closer together whenthe first and second vertebrae are aligned to interlock the first andsecond vertebral supports.

31. The method of any one of examples 20-30 wherein affixing the firstand second vertebral supports to anterior portions of the first andsecond vertebrae, respectively, comprises:

affixing a first anterior portion of the first vertebral support to theanterior portion of the first vertebrae such that a first intervertebralportion extends in a posterior direction from the first anterior portioninto intervertebral space between the first and second vertebrae; and

affixing a second anterior portion of the second vertebral support tothe anterior portion of the second vertebrae such that a secondintervertebral portion extends in a posterior direction from the secondanterior portion into interbody space between the first and secondvertebrae.

32. The method of any one of examples 20-31 wherein affixing the firstand second vertebral supports to anterior portions of the first andsecond vertebrae, respectively, comprises:

affixing the first vertebral support to the first vertebra positioned ina lumbar spine of the patient, wherein the first vertebra is anteriorlymisaligned with the second vertebra.

33. The method of any one of examples 20-32, further comprisinginserting bone graft around the first and second vertebral supports forlong-term arthrodesis and boney fusion of the first and secondvertebrae.

CONCLUSION

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of the technologyas those skilled in the relevant art will recognize. For example,although steps are presented in a given order, alternative embodimentsmay perform steps in a different order. The various embodimentsdescribed herein may also be combined to provide further embodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

We claim:
 1. A spinal implant system, comprising: a first vertebralsupport having a first anterior portion configured to be affixed to ananterior region of a first vertebra of a patient, the first vertebralsupport having a first intervertebral portion that extends within aspace between the first vertebra and the second vertebra, wherein thefirst intervertebral portion comprises a first engagement feature; asecond vertebral support having a second anterior portion configured tobe affixed to an anterior region of the second vertebra, the secondvertebral support having a second intervertebral portion that extendswithin the space between the first vertebra and the second vertebra,wherein the second intervertebral portion comprises a second engagementfeature, and wherein the first and second engagement features areconfigured to interlock with each other; and an alignment systemconfigured to operably couple to the first vertebral support and to thesecond vertebral support to adjust an angular, vertical, and linearposterior alignment of the first and second vertebral support relativeto each other when affixed to the first and second vertebrae.
 2. Thespinal implant system of claim 1, wherein the alignment systemcomprises: a first attachment component configured to releasably attachto the first vertebral support; a second attachment component configuredto releasably attach to the second vertebral support; and a distractionassembly configured to be operably coupled to the first attachmentcomponent and to the second attachment component, wherein thedistraction assembly is configured to vertically displace the firstvertebral support relative to the second vertebral support when coupledto the first and second vertebrae.
 3. The spinal implant system of claim2, wherein the first attachment component comprises a first shaft and atube configured to receive the first shaft, the tube having at least afirst hole, and wherein the second attachment component comprises asecond shaft having a plurality of second holes extending along a lengthof the second shaft.
 4. The spinal implant system of claim 1, whereinthe first vertebral support is uncoupled from the second vertebralsupport prior to the first engagement feature being interlocked with thesecond engagement feature.
 5. The spinal implant system of claim 1,further comprising an anterior reinforcement plate sized and shaped tofixedly attach to a medial portion of the first vertebral support andthe second vertebral support.
 6. The spinal implant system of claim 5,wherein the anterior reinforcement plate is a rigid reinforcement plate.7. A spinal implant system, comprising: a first vertebral support havinga first anterior portion configured to be affixed to an anterior regionof a first vertebra of a patient, the first vertebral support having afirst intervertebral portion that extends within a space between thefirst vertebra and the second vertebra, wherein the first intervertebralportion comprises a first engagement feature; and a second vertebralsupport having a second anterior portion configured to be affixed to ananterior region of the second vertebra, the second vertebral supporthaving a second intervertebral portion that extends within the spacebetween the first vertebra and the second vertebra, wherein the secondintervertebral portion comprises a second engagement feature, andwherein the first and second engagement features are configured tointerlock with each other, wherein the first engagement feature includesa first raised ledge and the second engagement feature includes a secondraised ledge, and wherein the first and second raised ledges areconfigured to engage with each other when the first engagement featureis interlocked with the second engagement feature.
 8. The spinal implantsystem of claim 7, wherein the first raised ledge comprises a firstcurved surface and the second raised ledge comprises a second curvedsurface, and wherein at least part of the first curved surface isconfigured to contact at least part of the second curved surface whenthe first engagement feature is interlocked with the second engagementfeature.
 9. The spinal implant system of claim 7, wherein the firstraised ledge comprises a first angled surface, wherein the second raisedledge comprises a second angled surface, and wherein at least part ofthe first angled surface is configured to contact at least part of thesecond angled surface when the first engagement feature is interlockedwith the second engagement feature.
 10. The spinal implant system ofclaim 7, further comprising an alignment system configured to operablycouple to the first vertebral support and to the second vertebralsupport, wherein the alignment system further comprises: a firstattachment component configured to releasably attach to the firstvertebral support; a second attachment component configured toreleasably attach to the second vertebral support; and a distractionassembly configured to be operably coupled to the first attachmentcomponent and to the second attachment component, wherein thedistraction assembly is configured to vertically displace the firstvertebral support relative to the second vertebral support when coupledto the first and second vertebrae.
 11. The spinal implant system ofclaim 10, wherein the first attachment component comprises a first shaftand a tube configured to receive the first shaft, the tube having atleast a first hole, and wherein the second attachment componentcomprises a second shaft having a plurality of second holes extendingalong a length of the second shaft.
 12. The spinal implant system ofclaim 7, wherein the first vertebral support is uncoupled from thesecond vertebral support prior to the first engagement feature beinginterlocked with the second engagement feature.
 13. The spinal implantsystem of claim 7, further comprising an anterior reinforcement platesized and shaped to fixedly attach to a medial portion of the firstvertebral support and the second vertebral support.
 14. The spinalimplant system of claim 13, wherein the anterior reinforcement plate isa rigid reinforcement plate.
 15. A spinal implant system, comprising: afirst vertebral support having a first anterior portion configured to beaffixed to an anterior region of a first vertebra of a patient, thefirst vertebral support having a first intervertebral portion thatextends within a space between the first vertebra and the secondvertebra, wherein the first intervertebral portion comprises a firstengagement feature; a second vertebral support having a second anteriorportion configured to be affixed to an anterior region of the secondvertebra, the second vertebral support having a second intervertebralportion that extends within the space between the first vertebra and thesecond vertebra, wherein the second intervertebral portion comprises asecond engagement feature, and wherein the first and second engagementfeatures are configured to interlock with each other; a plurality offirst screws configured to attach the first vertebral support to thefirst vertebra, wherein the first screws are configured to extendthrough two separate portions of cortical bone of the first vertebra andenter the first vertebra through an anterior face of the first vertebra;and a plurality of second screws configured to attach the secondvertebral support to the second vertebra, wherein the second screws areconfigured to extend through two separate portions of cortical bone ofthe second vertebra and enter the second vertebra through the anteriorface of the second vertebra.
 16. The spinal implant system of claim 15,further comprising an alignment system configured to operably couple tothe first vertebral support and to the second vertebral support, whereinthe alignment system further comprises: a first attachment componentconfigured to releasably attach to the first vertebral support; a secondattachment component configured to releasably attach to the secondvertebral support; and a distraction assembly configured to be operablycoupled to the first attachment component and to the second attachmentcomponent, wherein the distraction assembly is configured to verticallydisplace the first vertebral support relative to the second vertebralsupport when coupled to the first and second vertebrae.
 17. The spinalimplant system of claim 16, wherein the first attachment componentcomprises a first shaft and a tube configured to receive the firstshaft, the tube having at least a first hole, and wherein the secondattachment component comprises a second shaft having a plurality ofsecond holes extending along a length of the second shaft.
 18. Thespinal implant system of claim 15, wherein the first vertebral supportis uncoupled from the second vertebral support prior to the firstengagement feature being interlocked with the second engagement feature.19. The spinal implant system of claim 15, further comprising ananterior reinforcement plate sized and shaped to fixedly attach to amedial portion of the first vertebral support and the second vertebralsupport.
 20. The spinal implant system of claim 19, wherein the anteriorreinforcement plate is a rigid reinforcement plate.